Manager, GMP Quality Systems & Compliance
The primary responsibility for this position will be establishing and managing the Quality Systems and GXP compliance activities with a focus on continual improvement. This is a key quality management role reporting to the Executive Director of Quality Assurance.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Responsibilities of the Manager will include, but are not limited to:
• Managing and administrating the internal and external Quality systems including CAPA, deviation, change control, OOS, Product complaints, and Training. Write and review SOPs as needed
• Providing leadership to and managing the daily activities of the QA Systems and Compliance (GMPs, Part 11).
• Assessing and approving quality system documentation including implementing and coordinating all activities relating to the control, distribution, maintenance and closure of GMP Quality documentation
• Providing leadership to ensure continual improvement of the Quality Systems.
• Ensuring management of changes associated with products and processes are carried out appropriately using science and risk-based assessment to determine the impact of change.
• Providing leadership to and managing the Internal and External Audit programs.
• Identifying compliance risks and developing sound rationale as basis for the observations.
• Support generation of Annual Product Reviews in compliance with the requirement of GMP and Regulations.
• Coordinating activities and supporting interactions during regulatory agency inspections and customer audits.
• Ensuring key performance indicators measure progress against quality objectives.
• Monitoring, communicating and acting on any emerging trends.
• Analyzing and exercising judgment on complex issues, guided by a thorough understanding of quality philosophy.
• Mentor personnel in the QA organization as requested by the Head of QA & Compliance.
• May provide supervision to the Document Control position as needed
• Support Quality Operations as needed
• Support other GXP activities as needed
KNOWLEDGE AND SKILL REQUIREMENTS:
• Bachelor’s degree in a scientific discipline.
• Minimum of 5-7 years experience in a Quality Assurance role in the pharmaceutical industry.
• Supervisory experience of at least 1 year preferred.
• Independent decision making with a high degree of initiative.
• Specialized knowledge of QA Systems and Compliance, business principles and departmental processes.
• Ability to work on complex problems in which analysis of situations or data.
• Effectively interacts with internal peers and site management to lead continuous improvement.
• Extensive knowledge of US/EMA GMP requirements and associated guidelines.
• Experience in implementation and administration of quality systems for drug product development, clinical and commercial manufacturing and quality control operations.
• Experience in Pharmaceutical Quality Assurance, including the ability to identify and resolve compliance issues.
• Experience in participating in pharmaceutical technology transfer teams.
• Experience in the qualification of facilities, utilities, equipment and processes.
• Ability to increase others knowledge of GMP regulations and guidance.
• Strong organization and written and oral communication skills.
• Ability to manage multiple duties and tasks.
• Ability to utilize knowledge and interpersonal skills to provide leadership, direction and development of others, both within the department and cross-functionally.
• PHYSICAL DEMANDS: While performing the duties of this job, the employee is required to stand, walk; sit; talk and hear. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and the ability to adjust focus.
• WORK ENVIRONMENT: The noise level in the work environment is usually moderate. 10 to 20% travel is required.
Rigel Pharmaceuticals, Inc. is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by the law.